US12172005B2 - Delivery devices and methods for leadless cardiac devices - Google Patents

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The distal holding section may be structured to have portions that flex and bend while allowing the implantable device to be recaptured within the distal holding section.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 14/919,233, filed Oct. 21, 2015, which claims priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 62/067,074, filed Oct. 22, 2014, the entirety of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to leadless cardiac devices and methods, such as leadless pacing devices and methods, and delivery devices and methods for such leadless devices.

BACKGROUND

A wide variety of medical devices have been developed for medical use, for example, cardiac use. Some of these devices include catheters, leads, pacemakers, and the like, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, delivery systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and delivery devices as well as alternative methods for manufacturing and using medical devices and delivery devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices, including delivery devices.

In a first example, a delivery device for delivering an implantable leadless pacing device may comprise a proximal section, a distal holding section extending distally of a distal end of the proximal section, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and wherein the distal holding section comprises a reinforcing element covered by a polymeric body, such as a reinforcing element embedded within a polymeric body.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a nitinol cage.

Alternatively or additionally to any of the examples above, in another example, the nitinol cage may comprise a distal band, a proximal band, and a plurality of struts extending between the distal band and the proximal band.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a helically wound coil embedded within the polymeric body.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may extend along a length of the distal holding section, the length extending from a point adjacent a distal tip of the distal holding section to a point distal to a proximal end of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may comprise a first polymer having a first durometer along the length of the helically wound coil and a second polymer having a second durometer extending from a proximal end of the helically wound coil to the proximal end of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the first durometer may be less than the second durometer.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may extend from a distal end region of the distal holding section to a proximal end region of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may comprise a proximal section having a first pitch and a distal section having a second pitch.

Alternatively or additionally to any of the examples above, in another example, the first pitch may be less than the second pitch.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a braided reinforcing element.

Alternatively or additionally to any of the examples above, in another example, the braided reinforcing element may comprise a proximal section having a first pitch and a distal section having a second pitch different from the first pitch.

Alternatively or additionally to any of the examples above, in another example, the device may further comprise one or more apertures extending through a wall of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, a density of the one or more apertures may increase from a proximal end to or toward a distal tip of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the one or more apertures may comprise a spiral cut extending along a length of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may comprise a predefined curved portion along a length thereof.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may comprise a shape memory polymer.

Alternatively or additionally to any of the examples above, in another example, a delivery device for delivering an implantable leadless pacing device may comprise a proximal section, a distal holding section extending distally of a distal end of the proximal section, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and wherein the distal holding section comprises a reinforcing element covered by a polymeric body, such as a reinforcing element embedded within a polymeric body.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a nitinol cage.

Alternatively or additionally to any of the examples above, in another example, the nitinol cage may comprise a distal band, a proximal band, and a plurality of struts extending between the distal band and the proximal band.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a helically wound coil embedded within the polymeric body.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may extend along a length of the distal holding section, the length extending from a point adjacent a distal tip of the distal holding section to a point distal to a proximal end of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may comprise a first polymer having a first durometer along the length of the helically wound coil and a second polymer having a second durometer extending from a proximal end of the helically wound coil to the proximal end of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the first durometer may be less than the second durometer.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may extend from a distal end of the distal holding section to or toward a proximal holding section.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil may comprise a proximal section having a first pitch and a distal section having a second pitch.

Alternatively or additionally to any of the examples above, in another example, the helically wound coil protrudes from an inner surface of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may comprise a braided reinforcing element embedded within the polymeric body.

Alternatively or additionally to any of the examples above, in another example, a delivery device for delivering an implantable leadless pacing device may comprise a proximal section, a distal holding section extending distally of a distal end of the proximal section, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and wherein the distal holding section comprises a polymeric body and one or more apertures extending through a wall of the polymeric body.

Alternatively or additionally to any of the examples above, in another example, a density of the one or more apertures may increase from a proximal end to or toward a distal tip of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the one or more apertures may comprise a spiral cut extending along a length of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, a pitch of the spiral cut may vary over the length of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the device may further comprise an ionically conductive coating disposed over an outer surface of the distal holding section and covering the one or more apertures.

Alternatively or additionally to any of the examples above, in another example, the device may further comprise a reinforcing element disposed adjacent a distal tip of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the reinforcing element may have a “C” shape configured to allow a distal end region of the distal holding section to expand.

Alternatively or additionally to any of the examples above, in another example, a delivery device for delivering an implantable leadless pacing device may comprise a proximal section, a distal holding section extending distally of a distal end of the proximal section, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and wherein the distal holding section comprises a predefined curved portion along a length thereof.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may straighten to extend generally parallel to a longitudinal axis of the proximal section when an implantable leadless pacing device is disposed within the cavity.

Alternatively or additionally to any of the examples above, in another example, the distal holding section may comprise a shape memory polymer.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify some of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIG.1 is a plan view of an example leadless pacing device implanted within a heart;

FIG.2 is a side view of an example delivery device for an implantable leadless cardiac pacing device;

FIG.3 is a partial cross-sectional side view of the distal portion of the delivery device ofFIG.2, showing the implantable leadless cardiac pacing device disposed therein;

FIG.4 is a partial cross-sectional side view of the distal portion of another illustrative delivery device, showing the implantable leadless cardiac pacing device disposed therein;

FIG.5 is a partial cross-sectional side view of the distal portion of another illustrative delivery device, showing the implantable leadless cardiac pacing device disposed therein;

FIG.6 is a partial cross-sectional side view of the distal portion of another illustrative delivery device, showing the implantable leadless cardiac pacing device disposed therein;

FIG.7A is a side view of the distal portion of another illustrative delivery device;

FIG.7B is a cross-sectional side view of the distal portion of the delivery device ofFIG.7A;

FIG.8A is a side view of the distal portion of another illustrative delivery device;

FIG.8B is a cross-sectional side view of the distal portion of the delivery device ofFIG.8A;

FIG.9 is a side view of the distal portion of another illustrative delivery device;

FIG.10A is a cross-sectional side view of the distal portion of another illustrative delivery device;

FIG.10B is a cross-sectional side view of the distal portion of the delivery device ofFIG.10B, showing the implantable leadless cardiac pacing device disposed therein;

FIG.11 is a partial sectional side view of the distal portion of another illustrative delivery device;

FIG.11A is a cross-sectional side view of the distal portion of the delivery device ofFIG.11, showing the implantable leadless cardiac pacing device disposed therein; and

FIG.12 is a partial sectional side view of the distal portion of another illustrative delivery device.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

The following detailed description should be read with reference to the drawings in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

Cardiac pacemakers provide electrical stimulation to heart tissue to cause the heart to contract and thus pump blood through the vascular system. Conventional pacemakers typically include an electrical lead that extends from a pulse generator implanted subcutaneously or sub-muscularly to an electrode positioned adjacent the inside or outside wall of the cardiac chamber. As an alternative to conventional pacemakers, self-contained or leadless cardiac pacemakers have been proposed. Leadless cardiac pacemakers are small capsules typically fixed to an intracardiac implant site in a cardiac chamber. The small capsule typically includes bipolar pacing/sensing electrodes, a power source (e.g. a battery), and associated electrical circuitry for controlling the pacing/sensing electrodes, and thus provide electrical stimulation to heart tissue and/or sense a physiological condition. It can be readily appreciated that the implantation of a leadless pacing device within a beating heart could become dislodged as the heart functions. Accordingly, it may be desirable for a leadless pacing device to include one or more anchoring mechanism or member to help securing the pacing device to the heart.

FIG.1 illustrates an example implantable leadless cardiac pacing device10 (e.g., a leadless pacemaker) implanted in a chamber of a heart H, such as the right ventricle RV. Theimplantable device10 may include a shell orhousing12 having aproximal end14 and adistal end16. Theimplantable device10 may include afirst electrode20 positioned adjacent to thedistal end16 of thehousing12 and asecond electrode22 positioned adjacent to theproximal end14 of thehousing12. For example,housing12 may include a conductive material and may be insulated along a portion of its length. A section alongproximal end14 may be free of insulation so as to definesecond electrode22. Theelectrodes20,22 may be sensing and/or pacing electrodes to provide electro-therapy and/or sensing capabilities. Thefirst electrode20 may be capable of being positioned against or otherwise contact the cardiac tissue of the heart H while thesecond electrode22 may be spaced away from thefirst electrode20, and thus spaced away from the cardiac tissue.

Theimplantable device10 may include a pulse generator (e.g., electrical circuitry) and a power source (e.g., a battery) within thehousing12 to provide electrical signals to theelectrodes20,22 and thus control the pacing/sensing electrodes20,22. Electrical communication between the pulse generator and theelectrodes20,22 may provide electrical stimulation to heart tissue and/or sense a physiological condition.

Theimplantable device10 may include afixation mechanism24 proximate thedistal end16 of thehousing12 configured to attach theimplantable device10 to a tissue wall of the heart H, or otherwise anchor theimplantable device10 to the anatomy of the patient. As shown inFIG.1, in some instances, thefixation mechanism24 may include one or more, or a plurality ofhooks26 anchored into the cardiac tissue of the heart H to attach theimplantable device10 to a tissue wall. In other instances, thefixation mechanism24 may include one or more, or a plurality of passive tines, configured to entangle with trabeculae within the chamber of the heart H and/or a helical fixation anchor configured to be screwed into a tissue wall to anchor theimplantable device10 to the heart H.

Theimplantable device10 may include adocking member30 proximate theproximal end14 of thehousing12 configured to facilitate delivery and/or retrieval of theimplantable device10. For example, the dockingmember30 may extend from theproximal end14 of thehousing12 along a longitudinal axis of thehousing12. The dockingmember30 may include ahead portion32 and aneck portion34 extending between thehousing12 and thehead portion32. Thehead portion32 may be an enlarged portion relative to theneck portion34. For example, thehead portion32 may have a radial dimension from the longitudinal axis of theimplantable device10 which is greater than a radial dimension of the neck portion from the longitudinal axis of theimplantable device10. The dockingmember30 may be configured to facilitate delivery of theimplantable device10 to the intracardiac site and/or retrieval of theimplantable device10 from the intracardiac site.Other docking members30 are contemplated.

One aspect of the current disclosure relates to the delivery device and/or system used, for example, to deliverdevice10 to a suitable location within the anatomy (e.g., the heart). As may be appreciated, the delivery device may need to be navigated through relatively tortuous anatomy to deliver thedevice10 to a suitable location. For instance, in some embodiments, the delivery device may be advanced through the vasculature to a target region. In some example cases the device may be advanced through a femoral vein, into the inferior vena cava, into the right atrium, through the tricuspid valve, and into the right ventricle. The target region for the delivery of thedevice10 may be a portion of the right ventricle, for example, a portion of the right ventricle near the apex of the heart. The target region may also include other regions of the heart (e.g., right atrium, left atrium, or left ventricle), blood vessels, or other suitable targets. It may be desirable to provide the delivery system with certain features that may allow for easier or better control for navigation or delivery purposes. It may also be desirable to provide the delivery system with certain features that may facilitate retrieval of theimplantable device10.

FIGS.2 and3 illustrate an example embodiment of adelivery device100, such as a catheter, that may be used to deliver thedevice10. Thedelivery device100 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection146, attached to the distal end of theproximal section140. Thedelivery device100 may also include aproximal hub portion154 attached to the proximal end of theproximal section140. In some embodiments, theproximal section140 may include at least a section thereof that has an outer diameter D2 that is less than the outer diameter D1 of at least a portion of the holdingsection146. (See e.g.FIG.3).

Thedistal holding section146 may be configured to receive theimplantable device10 therein. For example, referring to bothFIGS.2 and3, the holdingsection146 may define acavity148 for slidably receiving theimplantable device10, and may include adistal opening150 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity148. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section146 may include abody portion145 and adistal tip portion147 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. For example, as the catheter is navigated through the anatomy, the distal tip may come into contact with anatomy. Additionally, when the catheter is used to deliver the device, thetip147 of thedelivery device100 will likely come into contact with tissue adjacent the target site (e.g. cardiac tissue of the heart). A hard distal tip formed of the material of the elongateproximal section140 may injure a vessel wall or cardiac tissue. As such, it may be desirable to provide thedelivery device100 with a softer distal tip that can be introduced into the anatomy and come into contact with anatomy adjacent the target site without causing unnecessary trauma.

For example, thedistal tip147 may be made of a material that is softer than thebody portion145 of the distal holding section. In some cases, thedistal tip147 may include a material that has a durometer that is less than the durometer of the material of thebody portion145. In some particular embodiments, the durometer of the material used in thedistal tip147 may be in the range of about 5 D to about 70 D, or for example, in the range of about 25 D to about 65 D. Additionally, thedistal tip147 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip147 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section146 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section146 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section146. For example, thedistal holding section146 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section146 may also define one or moreconductive pathways151 that are spaced proximally from thedistal opening150 in the distal end of the distal holding section. For example, theconductive pathways151 may include one or more openings through the wall of thedistal holding section146 that allow for fluid communication there through of a conductive fluid, such as blood. Such a conductive pathway may allow for conductive communication betweenelectrodes20,22 on thedevice10 through thedistal opening150 and thepathway openings151 respectively, while the device is housed within thecavity148. Such communication may allow thedevice10 to be tested prior to being released or delivered out of thecavity148. Other conductive pathways are also contemplated. For example, the one or more conductive pathways may include one or more sections defined in the wall of thedistal holding section146 that comprises a conductive material, such as conductive metals, polymers, and the like. In at least some embodiments, thedistal holding section146 may be free of theconductive pathways151.

Apush member160 may be disposed (e.g., slidably disposed) within a lumen of thedelivery device100. Thepush member160 may be engaged by a user near the proximal end of thedelivery device100, and extend through a lumen in thedelivery device100, through theproximal section140 and into thedistal holding section146. Adistal portion164 of thepush member160 may be capable of engaging thedevice10, and thepush member160 may be used to “push”device10 out fromdistal holding section146 so as to deploy andanchor device10 within a target region (e.g., a region of the heart such as the right ventricle).

In order to more specifically place or steerdelivery device100 to a position adjacent to the intended target,delivery device100 may be configured to be deflectable or articulable or steerable. Referring toFIG.2, for example, theproximal section140 may include one or more articulation or deflection mechanism(s) that may allow for thecatheter100, or portions thereof, to be deflected, articulated, steered and/or controlled in a desired manner. For example, theproximal section140 may include a shaft, such as atubular shaft member142 that includes at least a portion thereof that can be selectively bent and/or deflected in a desired or predetermined direction. This may, for example, allow a user to orient thedelivery device100 such that the holdingsection146 is in a desirable position or orientation for navigation or delivery of thedevice10 to a target location. As shown inFIG.2, theshaft member142 may be deflected, for example, alongdeflection region143 from a first example position indicated in phantom lines, to a second example position indicated in solid lines along a deflection path152.

A wide variety of deflection mechanisms may be used. In some example embodiments, deflection may be affected by one or more actuation members, such as pull wire(s) extending between a distal portion of thecatheter shaft member142 and anactuation mechanism156 near the proximal end of theshaft member142. As such, the one or more pull wires may extend both proximally and distally of the desired deflection or bending region or point. This allows a user to actuate (e.g., “pull”) one or more of the pull wires to apply a compression and/or deflection force to at least a portion of theshaft142 and thereby deflect or bend theshaft member142 in a desired manner. In addition, in some cases the one or more wires may be stiff enough so that they can also be used to provide a pushing and/or tensioning force on theshaft member142, for example, to “push” or “straighten” the shaft into a desired position or orientation.

In some embodiments, the actuation member takes the form of a continuous wire that is looped through or otherwise coupled to a distal end of theshaft member142 so as to define a pair of wire sections. Other embodiments are contemplated, however, including embodiments where the actuation member includes one or a plurality of individual wires that are attached, for example, to the distal end of theshaft member142.

Theactuation mechanism156 may include a desired mechanism that may allow for applying tension (i.e. pulling force), or compression (i.e. pushing force), or both, on the actuation member(s). In some embodiments, theactuation mechanism156 may include an externalrotatable member158 connected to and rotatable about the longitudinal axis of thehub154. Therotatable member158 may threadingly engage an internal member that is attached to the proximal end of the actuation member(s) or pull wires. When the externalrotatable member158 is rotated in a first rotational direction, the internal member translates in a first longitudinal direction, thereby applying tension to the pull wires, which applies compression force to the shaft, so as to deflect theshaft member142 from an initial position to a deflected position. When the externalrotatable member158 is rotated in a second rotational direction, the internal member translates in a second longitudinal direction, thereby releasing the tension on the pull wires, and allowing theshaft member142 to relax back toward the initial position. Additionally, in some cases, as mentioned above, where the one or more wires may be sufficiently rigid, rotation of therotatable member158 in the second rotational direction such that the internal member translates in a second longitudinal direction may apply compression to the wires, such that the wires may apply tension to theshaft member142 and “push” theshaft member142 back toward an initial position, and possibly into additional positions beyond the initial position.

The one or more articulation and/or deflection mechanism(s) may also entail theshaft member142 including structure and/or material that may provide for the desired degree and/or location of the deflection when the compressive or tensile forces are applied. For example, theshaft member142 may include one or more sections that include structure and/or material configured to allow the shaft to bend and/or deflect in a certain way when a certain predetermined compressive and/or tensile force is applied. For example, the shaft may include one or more sections that are more flexible than other sections, thereby defining a bending or articulating region or location. Some such regions may include a number of varying or changing flexibility characteristics that may define certain bending shapes when predetermined forces are applied. Such characteristics may be achieved through the selection of materials or structure for different sections of theshaft member142.

In other embodiments, other articulation and/or deflection mechanism(s) are contemplated. For example, all or a portion of thedelivery device100, such as theproximal section140, such asshaft member142, may be made of a shape memory material, such as a shape memory polymer and/or a shape memory metal. Such materials, when stimulated by an actuation mechanism, such as a change in temperature or the application of an electrical current, may change or move from a first shape to a second shape. As such, these materials and mechanisms may be used to deflect or bend theshaft member142 in a desired manner. Other suitable deflection mechanism(s) that are able to deflect thedelivery device100 may also be used. For example, at least a portion of theshaft member142, or other component of thedelivery device100, may include an electroactive polymer (EAP) which may be electrically activated to selectively deflect thedelivery device100. Such alternative mechanisms may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Furthermore, theshaft member142 may include one or more predefined or fixed curved portion(s) along the length thereof. In some cases, such curved sections may be configured to fit with particular anatomies or be configured for better navigation or delivery of thedevice10. Additionally, or alternatively, some such curved sections may be configured to allow theshaft member142 to be predisposed to be bent and/or deflected in a certain direction or configuration when compression and/or tension forces are applied thereto.

FIG.4 illustrates a partial cross-sectional side view of the distal portion of adelivery device200, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device200 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection246, attached to the distal end of theproximal section140. Thedistal holding section246 may be configured to receive theimplantable device10 therein. For example, the holdingsection246 may define a cavity248 for slidably receiving theimplantable device10, and may include adistal opening250 for slidable insertion and/or extraction of theimplantable device10 into and/or out of the cavity248. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section246 may include abody portion245 and adistal tip portion247 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip247 may be made of a material that is softer than thebody portion245 of thedistal holding section246, although this is not required. In some cases, thedistal tip247 may include a material that has a durometer that is less than the durometer of the material of thebody portion245. In some particular embodiments, the durometer of the material used in thedistal tip247 may be in the range of about 5 D to about 70 D, or for example, in the range of about 25 D to about 65 D. Additionally, thedistal tip247 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip247 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section246 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section246 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section246. For example, thedistal holding section246 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

In some instances, it may be desirable for thedistal holding section246 to be flexible and bendable. This may allow thedistal holding section246 to be more easily aligned with theimplantable device10 in the event it needs to be recaptured within thedistal holding section246. However, it may be necessary for thedistal holding section246 to have some rigidity to allow theimplantable device10 to be drawn back into thedistal holding section246 if thedevice10 needs to be relocated or otherwise moved. For example, it may be desirable for thedistal holding section246 to have some structure to prevent thedistal holding section246 from collapsing on itself, which may hinder and/or prevent recapturing thedevice10. It is contemplated that thebody portion245 may be formed from a flexible material. In some instances, thebody portion245 may be a polymeric body formed from a material such as, but not limited to, silicone rubber, polyurethane (PU), or poly(ethylene glycol) (PEG). These are just examples. Thepolymeric body245 may have a durometer in the range of about 20 D to about 50 D, about 30 D to about 40 D or about 35 D, for example.

Thedistal holding section246 may further include a reinforcingelement270 covered by thepolymeric body245, such as embedded within thepolymeric body245. The reinforcingelement270 may be configured to provide a stable structure to thedistal holding section246 while still allowing thedistal holding section246 to flex and bend to facilitate retrieval of thedevice10. In some instances, the reinforcingelement270 may include a metal or polymeric cage including aproximal band272 positioned adjacent to a proximal end of thedistal holding section246 and/or adistal band274 positioned adjacent to thedistal tip347. Theproximal band272 and/or thedistal band274 may be connected by one or more wires or struts276. In some instances, the reinforcingelement270 may be formed from nitinol. This is just an example. In some embodiments, the reinforcingelement270 may include radiopaque properties to facilitate delivery and/or retrieval of theimplantable device10.

It is contemplated that the reinforcingelement270 may include one or more bands in addition to the proximal and/ordistal bands272,274. It is further contemplated that the reinforcingelement270 may include only one of the proximal ordistal bands272,274. In some instances, the proximal and/ordistal bands272,274 may be circular or generally form a complete ring. In other instances, the proximal and/ordistal bands272,274 may not form a complete ring. For example, the proximal and/ordistal bands272,274 may have a “C” shape. It is further contemplated that the proximal and/ordistal bands272,274 may have any cross-sectional shape desired, such as, but not limited to, square, round, rectangular, pill-shaped, oval, polygonal, diamond, etc. Theproximal band272 and thedistal band274 may have the same shape or different shapes, as desired. The proximal anddistal bands272,274 may be connected by connectors, such as a plurality of wires or struts276 extending between theproximal band272 and thedistal band274. There may be one, two, three, four, ormore struts276 connecting theproximal band272 and thedistal band274, as desired, and may be symmetrically or asymmetrically circumferentially arranged around thedistal holding section246. Thestruts276 may have any cross-sectional shape desired, such as, but not limited to, circular, square, rectangular, oval polygonal, etc.

While the reinforcingelement270 is described as embedded within thepolymeric body245, it is contemplated that thedistal holding section246 may be formed in other manners. For example, a polymeric jacket may be disposed over the inner and/or outer surface of the reinforcingelement270. It is contemplated that a polymeric material may be extruded or heat shrunk over the reinforcingelement270. In some instances, thedistal holding section246 may be injection molded with the reinforcingelement270. These are just examples.

FIG.5 illustrates a partial cross-sectional side view of the distal portion of anotherillustrative delivery device300, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device300 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection346, attached to the distal end of theproximal section140. Thedistal holding section346 may be configured to receive theimplantable device10 therein. For example, the holdingsection346 may define acavity348 for slidably receiving theimplantable device10, and may include adistal opening350 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity348. Thedistal holding section346, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section346. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section346 may include abody portion345 and adistal tip portion347 that may be, for example, configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip347 may be made of a material that is softer than thebody portion345 of the distal holding section, although this is not required. In some cases, thedistal tip347 may include a material that has a durometer that is less than the durometer of the material of thebody portion345. Additionally, thedistal tip347 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip347 may have a distal surface, such as a tissue contacting surface, that is that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section346 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section346 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section346. For example, thedistal holding section346 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section346 may have aproximal section380 formed from a first material having a first durometer and adistal section382 formed from a second material having a second durometer. In some instances, the first durometer may be greater than the second durometer. For example, the first durometer may be in the range of about 60 D to about 80 D, about 65 D to about 75 D or about 70 D. The second durometer may be in the range of about 20 D to about 50 D, about 30 D to about 40 D or about 35 D, for example. For example, theproximal section380 may be formed from a 72 D polyether block amide and thedistal section382 may be formed from a 35 D polyether block amide. This is just an example. In some instances, thedistal section382 may include a reinforcing element, such as an embeddedcoil384. Thecoil384 may extend over a length extending proximally from a point adjacent thedistal tip347. It is contemplated that thecoil384 may extend over any length of thedistal holding section346 desired. The reinforcingelement384 may be configured to provide a stable structure to thedistal section382 while still allowing thedistal section382 to flex and bend to facilitate retrieval of thedevice10. In some embodiments, the reinforcing element orcoil384 may extend from an inner surface of thedistal holding section346. This may create a helical or threaded path to engage a mating threaded region (not explicitly shown) on theimplantable device10. In some instances, the reinforcing element orcoil384 may be formed from stainless steel. This is just an example. In some embodiments, the reinforcing element orcoil384 may include radiopaque properties to facilitate delivery and/or retrieval of theimplantable device10.

As can be appreciated, the spacing of adjacent windings (pitch), the size, and/or shape of thecoil384 may be varied to achieve the desired characteristics. For example, a coil having a larger pitch (greater distance between adjacent windings) may be more flexible than a similarly sized and shaped coil having a smaller pitch. The filament or strut forming the reinforcing element orcoil384 may have any cross-sectional shape desired, such as, but not limited to, circular, square, rectangular, ovoid, polygonal, etc. While the reinforcingelement384 is described as embedded within thedistal section382, it is contemplated that thedistal holding section346 may be formed in other manners. For example, a polymeric jacket may be disposed along the inner and/or outer surface of the reinforcingelement384. It is contemplated that a polymeric material may be extruded or heat shrunk over the reinforcingelement384. These are just examples. In some instances, thedistal section382 may be injection molded with the reinforcingelement384. In other instances, thedistal section382 may be reflowed proximally to partially extend over theproximal section380.

FIG.6 illustrates a partial cross-sectional side view of the distal portion of anotherillustrative delivery device400, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device400 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection446, attached to the distal end of theproximal section140. Thedistal holding section446 may be configured to receive theimplantable device10 therein. For example, the holdingsection446 may define acavity448 for slidably receiving theimplantable device10, and may include adistal opening450 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity448. Thedistal holding section446, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section446. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section446 may include abody portion445 and adistal tip portion447 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip447 may be made of a material that is softer than thebody portion445 of the distal holding section, although this is not required. In some cases, thedistal tip447 may include a material that has a durometer that is less than the durometer of the material of thebody portion445. Additionally, thedistal tip447 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip447 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section446 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section446 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section446. For example, thedistal holding section446 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section446 may further include a reinforcingelement484 covered by thepolymeric body445, such as embedded within thepolymeric body445. The reinforcingelement484 may be configured to provide a stable structure to thedistal holding section446 while still allowing thedistal holding section446 to flex and bend to facilitate retrieval of thedevice10. In some instances, the reinforcingelement484 may include an embedded coil. Thecoil484 may extend proximally from a point adjacent thedistal tip447. It is contemplated that thecoil484 may extend over any length of thedistal holding section446 desired. In some instances, the reinforcing element orcoil484 may be formed from stainless steel. This is just an example. In some embodiments, the reinforcing element orcoil484 may include radiopaque properties to facilitate delivery and/or retrieval of theimplantable device10. The filament or strut forming the reinforcing element orcoil484 may have any cross-sectional shape desired, such as, but not limited to, circular, square, rectangular, ovoid, polygonal, etc.

In some instances, thecoil484 may include aproximal section486 and adistal section488. Theproximal section486 may be formed such that the distance between adjacent windings of thecoil484 is different (e.g., less than or greater than) a distance between adjacent windings of thedistal section488. For example, thecoil484 may be more tightly wound over a length of theproximal section486 than over a length of thedistal section488. In other embodiments, thedistal section488 may be more tightly wound than theproximal section486. Thepolymeric body445 may be formed from a material having a durometer in the range of about 20 D to about 50 D, about 30 D to about 40 D or about 35 D, for example. For example, thepolymeric body445 may be formed from a 35 D polyether block amide. This is just an example. The reinforcing element orcoil484 may provide pushability over the proximal section486 (or tightly wound section) and flexibility over the distal section488 (or less tightly wound section). For example, the reinforcingelement484 may be configured to provide a pushable structure resistant to collapse while still allowing thedistal holding section446 to flex and bend to facilitate retrieval of thedevice10. As can be appreciated, the spacing of adjacent windings (pitch), the size, and/or shape of thecoil484 may be varied to achieve the desired characteristics. For example, a coil having a larger pitch (greater distance between adjacent windings) may be more flexible than a similarly sized and shaped coil having a smaller pitch.

While the reinforcingelement484 is described as embedded within thepolymeric body445, it is contemplated that thedistal holding section446 may be formed in other manners. For example, a polymeric jacket may be disposed along the inner and/or outer surface of the reinforcingelement484. It is contemplated that a polymeric material may be extruded or heat shrunk over the reinforcingelement484. These are just examples. In some instances, thepolymeric body445 may be injection molded with the reinforcingelement484. In some instances, the reinforcing element orcoil484 may extend from an inner surface of thedistal holding section446. This may create a helical or threaded path to engage a mating threaded region (not explicitly shown) on theimplantable device10.

FIG.7A illustrates a side view of the distal portion of anotherillustrative delivery device500, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same.FIG.7B illustrates a cross-sectional view of the distal portion of thedelivery device500 ofFIG.7A taken at line7B-7B. Thedelivery device500 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection546, attached to the distal end of theproximal section140. Thedistal holding section546 may be configured to receive theimplantable device10 therein. For example, the holdingsection546 may define a cavity548 (see, e.g.,FIG.7B) for slidably receiving theimplantable device10, and may include adistal opening550 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity548. Thedistal holding section546, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section546. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section546 may include abody portion545 and adistal tip portion547 that may be, for example, configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip547 may be made of a material that is softer than thebody portion545 of the distal holding section, although this is not required. In some cases, thedistal tip547 may include a material that has a durometer that is less than the durometer of the material of thebody portion545. Additionally, thedistal tip547 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip547 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section546 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section546 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section546. For example, thedistal holding section546 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thebody portion545 may be formed from any material desired. In some instances, thebody portion545 may be formed from a material having a durometer in the range of about 60 D to about 80 D, about 65 D to about 75 D or about 70 D. Thebody portion545 may include a plurality of cuts orapertures549 to provide a degree of lateral flexibility and/or vary the stiffness along the length of thedistal holding section546. For example, thebody portion545 may include a thin wall tubular structure including one or more apertures orcuts549, for example grooves, slits, slots, holes, openings, or the like, formed in a portion of, or along the entire length of thebody portion545. The apertures orcuts549 can be formed in essentially any known way. For example, apertures orcuts549 can be formed by methods such as micro-machining, saw-cutting, laser cutting, grinding, milling, casting, molding, chemically etching or treating, drilling, or other known methods, and the like.

In some embodiments, the apertures orcuts549 may completely penetrate the body wall of thebody portion545. In other cases, only some of the apertures orcuts549 completely penetrate the body wall. In such cases, some or all of the apertures orcuts549 may only partially extend into the body wall of thebody portion545, either on the interior or exterior surface thereof. The shape and size of the apertures orcuts549 can vary to achieve the desired characteristics. For example, the shape of apertures orcuts549 can vary to include essentially any appropriate shape, such as, but not limited to square, triangular, round, rectangular, pill-shaped, oval, polygonal, diamond, elongate, irregular, spiral (which may or may not vary in pitch), or other suitable means or the like, and may include rounded or squared edges, and can be variable in length and width, total open area, and the like. In some instances, the apertures orcuts549 may have a generally rectangular shape with the major length of the rectangle extending generally parallel to a longitudinal axis of theproximal section140. In other instances, the apertures orcuts549 may have a major length that extends generally perpendicular to the longitudinal axis of theproximal section140 or at an oblique angle to the longitudinal axis of theproximal section140.

In some embodiments, some adjacent apertures orcuts549 can be formed such that they include portions that overlap with each other about the circumference of thebody portion545. In other embodiments, some adjacent apertures orcuts549 can be disposed such that they do not necessarily overlap with each other, but are disposed in a pattern that provides the desired degree and/or direction of lateral flexibility. For example, the apertures orcuts549 can be arranged in a symmetrical pattern, such as being disposed essentially equally on opposite sides about the circumference of thebody portion545, or equally spaced along the length of thebody portion545.

As can be appreciated, the spacing, arrangement, and/or orientation of the apertures orcuts549 can be varied to achieve the desired characteristics. For example, the number, proximity (to one another), density, size, shape and/or depth of the apertures orcuts549 along the length of thebody portion545 may vary in either a stepwise fashion or continuously, depending upon the desired characteristics. For example, the number or proximity of apertures orcuts549 to one another near one end of thebody portion545 may be high, while the number or proximity of apertures orcuts549 to one another at another longitudinal location along thebody portion545 may be relatively low. In some embodiments, portions closer to thedistal tip547 may include a greater density of apertures orcuts549, while proximal regions of thebody portion545 may include a lesser density of apertures orcuts549, or may even be devoid of any apertures or cuts549. As such, the portions of thedistal holding section546 closer to thedistal tip547 can have a greater degree of lateral flexibility relative to proximal regions of thedistal holding section546.

Thedistal holding section546 may further include a thin coating or jacket551 (see, e.g.FIG.7B) on an inner and/or outer surface of thebody portion545. In order to more clearly illustrate the apertures orcuts549, thecoating551 has been omitted fromFIG.7A. In some embodiments, thecoating551 may be an ionically permeable coating. This may allow for electrical communication there through forming a conductive pathway. Such a conductive pathway may allow for conductive communication betweenelectrodes20,22 on the device10 (not explicitly shown) through thedistal opening550 and the apertures orcuts549 respectively, while the device is housed within thecavity548. Such communication may allow thedevice10 to be tested prior to being released or delivered out of thecavity548. Thecoating551 may also allow a contrast agent to be delivered through a lumen of thedelivery device500 and exit through thedistal opening550 without exiting through the apertures or cuts549.

FIG.8A illustrates a side view of the distal portion of anotherillustrative delivery device600, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same.FIG.8B illustrates a cross-sectional view of the distal portion of thedelivery device600 ofFIG.8A taken atline8B-8B. Thedelivery device600 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection646, attached to the distal end of theproximal section140. Thedistal holding section646 may be configured to receive theimplantable device10 therein. For example, the holdingsection646 may define a cavity648 (see, e.g.,FIG.8B) for slidably receiving theimplantable device10, and may include adistal opening650 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity648. Thedistal holding section646, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section646. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section646 may include abody portion645 and adistal tip portion647 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip647 may be made of a material that is softer than thebody portion645 of the distal holding section, although this is not required. In some cases, thedistal tip647 may include a material that has a durometer that is less than the durometer of the material of thebody portion645. Additionally, thedistal tip647 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip647 may have a distal surface, such as a tissue contacting surface, that is that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section646 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section646 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section646. For example, thedistal holding section646 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thebody portion645 may be formed from any material desired. In some instances, thebody portion645 may be formed from a material having a durometer in the range of about 60 D to about 80 D, about 65 D to about 75 D or about 70 D. Thebody portion645 may include one or more spiral cuts orapertures649 to provide a degree of lateral flexibility and/or vary the stiffness along the length of thedistal holding section646. For example, thebody portion645 may include a thin wall tubular structure including one or more spiral apertures orcuts649, for example grooves, slits, slots, or the like, formed in a portion of, or along the entire length of, thebody portion645. The apertures orcuts649 can be formed in essentially any known way. For example, the spiral aperture or cut649 can be formed by methods such as micro-machining, saw-cutting, laser cutting, grinding, milling, casting, molding, chemically etching or treating, drilling, or other known methods, and the like.

In some embodiments, the aperture or cut649 may completely penetrate the body wall of thebody portion645. In other cases, the aperture or cut649 may not completely penetrate the body wall of thebody portion645, or only some or a portion of the aperture or cut649 completely penetrates the body wall. In such cases, some or all of the aperture or cut649 may only partially extend into the body wall of thebody portion645, either on the interior or exterior surface thereof. The shape and size of the aperture or cut649 can vary to achieve the desired characteristics. For example, the thickness of the aperture or cut649 can vary as well as the pitch to achieve the desired flexibility. For example, an aperture or cut649 having a smaller pitch (e.g. smaller distance between adjacent windings) may result in a more flexibledistal holding section646 than an aperture or cut649 having a larger pitch. It is further contemplated thebody portion645 may include more than one spiral aperture or cut649.

As can be appreciated, the spacing, arrangement, and/or orientation of the aperture(s) or cut(s)649 can be varied to achieve the desired characteristics. For example, the number, proximity (to one another), density, size, shape and/or depth of the aperture(s) or cut(s)649 along the length of thebody portion645 may vary in either a stepwise fashion or continuously, depending upon the desired characteristics. For example, the pitch of the windings of the aperture(s) or cut(s)649 to one another near one end of thebody portion645 may be small, while the pitch of the windings of the aperture(s) or cut(s)649 to one another at another longitudinal location along thebody portion645 may be relatively large. In some embodiments, portions closer to thedistal tip647 may include a smaller pitched aperture or cut649, while thebody portion645 proximal regions may include a larger pitched of aperture or cut649, or may even be devoid of any apertures or cuts649. As such, the portions of thedistal holding section646 closer to thedistal tip647 can have a greater degree of lateral flexibility relative todistal holding section646 proximal regions.

Thedistal holding section646 may further include a thin coating or jacket651 (see, e.g.FIG.8B) on an inner and/or outer surface of thebody portion645. In order to more clearly illustrate the apertures orcuts649, thecoating651 has been omitted fromFIG.8A. In some embodiments, thecoating651 may be an ionically permeable coating. This may allow for electrical communication there through forming a conductive pathway. Such a conductive pathway may allow for conductive communication betweenelectrodes20,22 on the device10 (not explicitly shown) through thedistal opening650 and the spiral apertures orcuts649 respectively, while the device is housed within thecavity648. Such communication may allow thedevice10 to be tested prior to being released or delivered out of thecavity648. Thecoating651 may also allow a contrast agent to be delivered through a lumen of thedelivery device600 and exit through thedistal opening650 without exiting through the apertures or cuts649.

In some instances, thedistal holding section646 may include a reinforcingelement653 positioned adjacent to thedistal tip647. The reinforcingelement653 may have a “C” shape configured to allow the distal end region of thedistal holding section646 to expand. For example, thebody portion645 may include a fold of excess material adjacent to the reinforcingelement653 to allow the distal end region to expand and accommodate animplantable device10. While the reinforcingelement653 is illustrated as having a generally rectangular cross-section, it is contemplated that the reinforcingelement653 may have any cross-sectional shape desired, such as, but not limited to, square, circular, oval, polygonal, etc.

FIG.9 illustrates a side view of the distal portion of anotherillustrative delivery device700, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device700 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection746, attached to the distal end of theproximal section140. Thedistal holding section746 may be configured to receive theimplantable device10 therein. For example, the holdingsection746 may define a cavity (not explicitly shown) for slidably receiving theimplantable device10, and may include adistal opening750 for slidable insertion and/or extraction of theimplantable device10 into and/or out of the cavity. Thedistal holding section746, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section746. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

In some embodiments, all or a portion of thedistal holding section746 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section746 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section746. For example, thedistal holding section746 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section746 may be formed from any material desired. In some instances, thedistal holding section746 may be formed from a material having a durometer in the range of about 60 D to about 80 D, about 65 D to about 75 D or about 70 D. In some instances, thedistal holding section746 may comprise a plurality of interconnected stent-like struts755. For example, thedistal holding section746 may be formed from a generally tubular member and altered to form a desired pattern. For example, the pattern ofstruts755 andconnectors759 may be formed by methods such as micro-machining, saw-cutting, laser cutting, grinding, milling, casting, molding, chemically etching or treating, drilling, or other known methods, and the like. While thedistal holding section746 is illustrated as having an open cell, generally stent-like, structure it is contemplated that thedistal holding section746 may be formed to have any of a number of different configurations. In some embodiments, thedistal holding section746 may be formed from a plurality of interconnected generally circumferentially extendingstruts755. Thestruts755 may be connected by one ormore connectors759. It is contemplated that thestruts755 in combination with theconnectors759 may form a cellular configuration with each cell having any shape desired, such as, but not limited to: circular, square, oval, rectangular, polygonal, etc. In some instances, thedistal holding section746 may be formed from a number of generally longitudinally extending tines or may be formed from one or more filaments that may be woven, braided, knotted, etc. These are just examples.

As can be appreciated, the spacing, arrangement, and/or orientation of thestruts755 orconnectors759 can be varied to achieve the desired characteristics. For example, the number, proximity (to one another), density, size, and/or shape of thestruts755 orconnectors759 along the length of thedistal holding section746 may vary in either a stepwise fashion or consistently, depending upon the desired characteristics. For example, closely positionedadjacent struts755 may have less flexibility thanadjacent struts755 positioned further from one another.

Thedistal holding section746 may further include a thin coating orjacket751 on an inner and/or outer surface of thedistal holding section746. In order to more clearly illustrate thestruts755 andconnectors759, thecoating751 is illustrated as disposed on an inner surface of thedistal holding section746. However, thecoating751 may be disposed over an outer surface of thedistal holding section746. In some embodiments, thecoating751 may be an ionically permeable coating. This may allow for electrical communication there through forming a conductive pathway. Such a conductive pathway may allow for conductive communication betweenelectrodes20,22 on the device10 (not explicitly shown) through thedistal opening750 and the regions betweenadjacent struts755 respectively, while the device is housed within the cavity. Such communication may allow thedevice10 to be tested prior to being released or delivered out of the cavity. Thecoating751 may also allow a contrast agent to be delivered through a lumen of thedelivery device700 and exit through the distal opening50 without exiting through the regions betweenadjacent struts755.

FIGS.10A and10B illustrate a partial cross-sectional side view of the distal portion of anotherillustrative delivery device800, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device800 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection846, attached to the distal end of theproximal section140. Thedistal holding section846 may be configured to receive theimplantable device10 therein. For example, the holdingsection846 may define acavity848 for slidably receiving theimplantable device10, and may include adistal opening850 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity848. Thedistal holding section846, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section846. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section846 may include abody portion845 and adistal tip portion847 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip847 may be made of a material that is softer than thebody portion845 of thedistal holding section846, although this is not required. In some cases, thedistal tip847 may include a material that has a durometer that is less than the durometer of the material of thebody portion845. Additionally, thedistal tip847 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip847 may have a distal surface, such as a tissue contacting surface, that is that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section846 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section846 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section846. For example, thedistal holding section846 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section846 may be formed to include a predefined or fixed curve portion(s) along a length thereof when animplantable device10 is not disposed within thecavity848, as shown inFIG.10A. In other words, the central axis X of thedistal holding section846 may be curved when thedistal holding section846 is in an equilibrium state. This may help align thedistal opening850 with animplantable device10 in the event it needs to be recaptured within thedistal holding section846. As theimplantable device10 is recaptured (or during initial loading and delivery of the implantable device) thedistal holding section846 may straighten to extend generally parallel with a longitudinal axis of theproximal section140. In other words, implantable device10 (which may include a rigid housing) may exert a force on thedistal holding section846 to straighten thedistal holding section846 away from its equilibrium curved state when inserted therein. Thus, the forces exerted by theimplantable device10 on the interior of thedistal holding section846 may straighten the central axis X to be generally parallel with the longitudinal axis of theimplantable device10 and thepush member160, as shown inFIG.10B.

In some instances, thedistal holding section846 may be formed from a shape memory material, although this is not required. In broad terms, shape memory polymers behave similarly to shape memory alloys such as the nickel-titanium alloys commonly referred to as nitinol. Shape memory polymers may be formed in a parent (or remembered) shape. The shape memory polymer may be temporarily deformed into another shape by heating the polymer above the transition temperature (in some instances this may be the glass transition temperature or the melting temperature), changing the shape of the polymer, and cooling the polymer while maintaining it in the temporary shape. An external stimulus, such as, but not limited to, heat, may be used to return the shape memory polymer to the remembered shape from the temporary shape. The shape memory polymer may be selected to be biocompatible.

FIG.11 illustrates a side view in partial section of the distal portion of anotherillustrative delivery device900, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device900 may include aproximal section140, such as a proximal shaft, and a distal section and/or holdingsection946, attached to the distal end of theproximal section140. Thedistal holding section946 may be configured to receive theimplantable device10 therein. For example, the holdingsection946 may define a cavity (not explicitly shown) for slidably receiving theimplantable device10, and may include adistal opening950 for slidable insertion and/or extraction of theimplantable device10 into and/or out of the cavity. Thedistal holding section946, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section946. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section946 may include abody portion945 and adistal tip portion947 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip947 may be made of a material that is softer than thebody portion945 of the distal holding section, although this is not required. In some cases, thedistal tip947 may include a material that has a durometer that is less than the durometer of the material of thebody portion945. Additionally, thedistal tip947 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip947 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue as seen inFIG.11A.

In some embodiments, all or a portion of thedistal holding section946 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section946 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section946. For example, thedistal holding section946 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section946 may further include a reinforcingelement984 covered by thepolymeric body945, such as embedded within thepolymeric body945. A portion of thepolymeric body945 is shown in partial section to more clearly illustrate the reinforcingelement984. The reinforcingelement984 may be configured to provide a stable structure to thedistal holding section946 while still allowing thedistal holding section946 to flex and bend to facilitate retrieval of thedevice10. In some instances, the reinforcingelement984 may include an embedded braided element formed from two or more filaments. While the reinforcingelement984 is described as braided, it is contemplated that the reinforcing element may be woven, wound, or otherwise intertwined. Thebraid984 may extend proximally from a point adjacent thedistal tip947. It is contemplated that thebraid984 may extend over any length of thedistal holding section946 desired. In some instances, the reinforcing element or braid984 may be formed from a metal, a metal alloy, such as nitinol, or a polymeric material. These are just examples. In some embodiments, the reinforcing element or braid984 may include radiopaque properties to facilitate delivery and/or retrieval of theimplantable device10. The filaments or struts forming the reinforcing element or braid984 may have any cross-sectional shape desired, such as, but not limited to, circular, square, rectangular, ovoid, polygonal, etc.

In some instances, thebraid984 may include aproximal section986, adistal section988, and anintermediate section987 disposed between theproximal section986 and thedistal section988. Theproximal section986,intermediate section987 anddistal section988 may each be formed such that the pitch of the braided elements between adjacent windings of thebraid984 is different (e.g., less than or greater than) a pitch between adjacent windings of the other sections. For example, theproximal section986 may have a first pitch, theintermediate section987 may have a second pitch which may be different than the first pitch, and thedistal section988 may have a third pitch which may different than the first and/or second pitches, although this is not required. For example, thebraid984 may be more tightly formed over a length of theproximal section986 and thedistal section988 than over a length of theintermediate section987. It is contemplated this arrangement may allow thedistal holding section946 to flex or bend to a greater extent over the less tightly formed region, such as theintermediate section987 inFIG.11. This is just an example. Other configurations are contemplated. For example, in other embodiments, theintermediate section987 may be more tightly wound than theproximal section986 and thedistal section988. It is further contemplated that theproximal section986 and thedistal section988 may have pitches different from one another. In some instances, theproximal section986 may be more tightly wound or formed (e.g. have a smaller pitch) than thedistal section988. The reverse configuration is also contemplated.

Thepolymeric body945 may be formed from a material having a durometer in the range of about 20 D to about 50 D, about 30 D to about 40 D or about 35 D, for example. For example, thepolymeric body945 may be formed from a 35 D polyether block amide. This is just an example. The reinforcing element or braid984 may provide pushability over theproximal section986 and/or distal section988 (or tightly wound section) and flexibility over the intermediate section987 (or less tightly wound section). For example, the reinforcingelement984 may be configured to provide a pushable structure resistant to collapse while still allowing thedistal holding section946 to flex and bend to facilitate retrieval of thedevice10. As can be appreciated, the spacing of adjacent windings (pitch), the size, and/or shape of thebraid984 may be varied to achieve the desired characteristics. For example, a braid having a larger pitch (greater distance between adjacent windings) may be more flexible than a similarly sized and shaped braid having a smaller pitch.

While the reinforcingelement984 is described as embedded within thepolymeric body945, it is contemplated that thedistal holding section946 may be formed in other manners. For example, a polymeric jacket may be disposed along the inner and/or outer surface of the reinforcingelement984. It is contemplated that a polymeric material may be extruded or heat shrunk over the reinforcingelement984. These are just examples. In some instances, thepolymeric body945 may be injection molded with the reinforcingelement984. In some instances, the reinforcing element or braid984 may extend from an inner surface of thedistal holding section946. This may create a helical or threaded path to engage a mating threaded region (not explicitly shown) on theimplantable device10.

In some instances, thedistal holding section946 may include an additional reinforcing element (not explicitly shown) positioned adjacent to thedistal tip947. The reinforcing element may have a “C” shape configured to allow the distal end region of thedistal holding section946 to expand. For example, thebody portion945 may include a fold of excess material adjacent to the reinforcing element to allow the distal end region to expand and accommodate animplantable device10. In some instances, the additional reinforcing element may have a generally rectangular cross-section. In other instances, it is contemplated that the reinforcing element may have any cross-sectional shape desired, such as, but not limited to, square, circular, oval, polygonal, etc. The additional reinforcing element may be formed from a radiopaque material or be doped with a radiopaque material.

FIG.12 illustrates a side view in partial section of the distal portion of anotherillustrative delivery device1000, such as a catheter, which is similar in many respects to that of thedelivery device100 shown inFIG.2, with similar structures numbered the same. Thedelivery device1000 may include aproximal section140, such as a proximal shaft, and a distal section and/orholding section1046, attached to the distal end of theproximal section140. Thedistal holding section1046 may be configured to receive theimplantable device10 therein. For example, theholding section1046 may define a cavity (not explicitly shown) for slidably receiving theimplantable device10, and may include adistal opening1050 for slidable insertion and/or extraction of theimplantable device10 into and/or out of the cavity. Thedistal holding section1046, or portions thereof, may be configured to have portions that flex and bend while allowing theimplantable device10 to be recaptured within thedistal holding section1046. Other suitable distal holding sections that are able to receive theimplantable device10 therein may also be used. Such alternative holding sections may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Thedistal holding section1046 may include abody portion1045 and adistal tip portion1047 that may, for example, be configured to be atraumatic to anatomy, such as a bumper tip. In some instances, thedistal tip1047 may be made of a material that is softer than thebody portion1045 of the distal holding section, although this is not required. In some cases, thedistal tip1047 may include a material that has a durometer that is less than the durometer of the material of thebody portion1045. Additionally, thedistal tip1047 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip1047 may have a distal surface, such as a tissue contacting surface, that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section1046 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality ofhooks26 on thedevice10. For example, thedistal holding section1046 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section1046. For example, thedistal holding section1046 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

Thedistal holding section1046 may further include a reinforcingelement1084 covered by thepolymeric body1045, such as embedded within thepolymeric body1045. A portion of thepolymeric body1045 is shown in partial section to more clearly illustrate the reinforcingelement1084. The reinforcingelement1084 may be configured to provide a stable structure to thedistal holding section1046 while still allowing thedistal holding section1046 to flex and bend to facilitate retrieval of thedevice10. In some instances, the reinforcingelement1084 may include an embedded braided element formed from two or more filaments. While the reinforcingelement1084 is described as braided, it is contemplated that the reinforcing element may be woven, wound, or otherwise intertwined. Thebraid1084 may extend proximally from a point adjacent thedistal tip1047. It is contemplated that thebraid1084 may extend over any length of thedistal holding section1046 desired. In some instances, the reinforcing element orbraid1084 may be formed from a metal, a metal alloy, such as nitinol, or a polymeric material. These are just examples. In some embodiments, the reinforcing element orbraid1084 may include radiopaque properties to facilitate delivery and/or retrieval of theimplantable device10. The filaments or struts forming the reinforcing element orbraid1084 may have any cross-sectional shape desired, such as, but not limited to, circular, square, rectangular, ovoid, polygonal, etc.

In some instances, thebraid1084 may include aproximal section1086 and adistal section1088. Theproximal section1086 and thedistal section1088 may each be formed such that the pitch of the braided elements between adjacent windings of thebraid1084 is different (e.g., less than or greater than) a pitch between adjacent windings of the other section. For example, thebraid1084 may have a first pitch, or be more tightly formed over a length of theproximal section1086 than thedistal section1088, which may have a second pitch. It is contemplated this arrangement may allow thedistal holding section1046 to flex or bend to a greater extent over the less tightly formed region, such as thedistal section1088 inFIG.12. This is just an example. Other configurations are contemplated. For example, in other embodiments, thedistal section1088 may be more tightly wound than theproximal section1086.

Thepolymeric body1045 may be formed from a material having a durometer in the range of about 20 D to about 50 D, about 30 D to about 40 D or about 35 D, for example. For example, thepolymeric body1045 may be formed from a 35 D polyether block amide. This is just an example. The reinforcing element orbraid1084 may provide pushability over the proximal section1086 (or tightly wound section) and flexibility over the distal section1088 (or less tightly wound section). For example, the reinforcingelement1084 may be configured to provide a pushable structure resistant to collapse while still allowing thedistal holding section1046 to flex and bend to facilitate retrieval of thedevice10. As can be appreciated, the spacing of adjacent windings (pitch), the size, and/or shape of thebraid1084 may be varied to achieve the desired characteristics. For example, a braid having a larger pitch (greater distance between adjacent windings) may be more flexible than a similarly sized and shaped braid having a smaller pitch.

While the reinforcingelement1084 is described as embedded within thepolymeric body1045, it is contemplated that thedistal holding section1046 may be formed in other manners. For example, a polymeric jacket may be disposed along the inner and/or outer surface of the reinforcingelement1084. It is contemplated that a polymeric material may be extruded or heat shrunk over the reinforcingelement1084. These are just examples. In some instances, thepolymeric body1045 may be injection molded with the reinforcingelement1084. In some instances, the reinforcing element orbraid1084 may extend from an inner surface of thedistal holding section1046. This may create a helical or threaded path to engage a mating threaded region (not explicitly shown) on theimplantable device10.

In some instances, thedistal holding section1046 may include an additional reinforcing element (not explicitly shown) positioned adjacent to thedistal tip1047. The reinforcing element may have a “C” shape configured to allow the distal end region of thedistal holding section1046 to expand. For example, thebody portion1045 may include a fold of excess material adjacent to the reinforcing element to allow the distal end region to expand and accommodate animplantable device10. In some instances, the additional reinforcing element may have a generally rectangular cross-section. In other instances, it is contemplated that the reinforcing element may have any cross-sectional shape desired, such as, but not limited to, square, circular, oval, polygonal, etc. The additional reinforcing element may be formed from a radiopaque material or be doped with a radiopaque material.

The materials that can be used for the various components of the delivery devices, such asdelivery devices100/200/300/400/500/600/700/800/900/1000 (and/or other delivery structures disclosed herein) and the various members disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference thedelivery devices100/200/300/400/500/600/700/800/900/1000 and components of thereof. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar delivery systems and/or components of delivery systems or devices disclosed herein.

Thedelivery devices100/200/300/400/500/600/700/800/900/1000 and/or other components of the delivery systems may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the polymer can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of thedelivery devices100/200/300/400/500/600/700/800/900/1000 and/or other components of the delivery systems may be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of thedelivery devices100/200/300/400/500/600/700/800/900/1000 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of thedelivery devices100/200/300/400/500/600/700/800/900/1000 to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into thedelivery devices100/200/300/400/500/600/700/800/900/1000. For example,delivery devices100/200/300/400/500/600/700/800/900/1000, or portions or components thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Thedelivery devices100/200/300/400/500/600/700/800/900/1000, or portions thereof, may also include and/or be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims (20)

What is claimed is:

1. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

a proximal elongate shaft having an outer diameter;

a distal holding section having a proximal end secured to a distal end of the proximal elongate shaft and extending distally of the distal end of the proximal elongate shaft, the distal holding section having an enlarged outer diameter greater than the outer diameter of the proximal elongate shaft, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device through a distal opening of the distal holding section into the cavity; and

wherein the distal holding section that defines the cavity comprises a predefined curved portion along a length thereof having the enlarged outer diameter such that a central axis through the cavity of the distal holding section is curved.

2. The delivery device ofclaim 1, wherein the distal holding section straightens such that the central axis of the distal holding section extends generally parallel to a longitudinal axis of the proximal section when an implantable leadless pacing device is disposed within the cavity.

3. The delivery device ofclaim 1, wherein the distal holding section comprises a shape memory polymer.

4. The delivery device ofclaim 1, wherein the distal holding section includes a body portion and a distal tip, the distal tip being made of a material having a lower durometer than a material forming the body portion.

5. The delivery device ofclaim 1, wherein the distal holding section incudes multiple layers, with an inner layer made of a material that is harder than an outer layer.

6. The delivery device ofclaim 1, wherein the distal holding section comprises a braided reinforcing element covered by a polymeric material.

7. The delivery device ofclaim 6, wherein a proximalmost end of the braided reinforcing element is disposed within the distal holding section.

8. The delivery device ofclaim 6, wherein the braided reinforcing element is embedded within the polymeric material.

9. The delivery device ofclaim 8, wherein the braided reinforcing element comprises a plurality of braided wires.

10. The delivery device ofclaim 9, wherein the braided reinforcing element includes a proximal section and a distal section, wherein a pitch of the plurality of braided wires in the proximal section of the braided reinforcing element is different than a pitch of the plurality of braided wires in the distal section of the braided reinforcing element.

11. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

an elongate shaft having an outer diameter and a lumen extending therethrough;

a distal end of the elongate shaft defining a distal holding section having an outer diameter greater than an outer diameter of a remainder of the elongate shaft;

a push member slidably disposed in the lumen of the elongate shaft;

wherein the distal holding section defines a cavity therein for receiving an implantable leadless pacing device and a distal opening for expelling the implantable leadless pacing device therefrom; and

wherein the distal holding section comprises a predefined curved portion along a length thereof, the predefined curved portion including the distal holding section having the outer diameter greater than the outer diameter of the remainder of the elongate shaft.

12. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:

a proximal elongate shaft having an outer diameter and a distal end;

a distal holding section extending distally from the distal end of the proximal elongate shaft, the distal holding section comprising:

a proximal end secured to the distal end of the proximal elongate shaft;

a body portion including an annular wall defining a cavity therein for receiving an implantable leadless pacing device;

a distal end having an opening that opens into the cavity;

a length extending from the proximal end of the distal holding section to the distal end of the distal holding section;

wherein the body portion that defines the cavity of the distal holding section includes a predefined curve extending along the length of the distal holding section between the proximal end of the distal holding section and the distal end of the distal holding section such that a central axis of the cavity of the body portion of the distal holding section is curved;

wherein the distal holding section has an outer diameter greater than the outer diameter of the proximal elongate shaft.

13. The delivery device ofclaim 12, wherein the body portion of the distal holding section straightens such that the central axis of the distal holding section body portion extends generally parallel to a longitudinal axis of the proximal section when an implantable leadless pacing device is disposed within the cavity.

14. The delivery device ofclaim 13, wherein the distal holding section comprises a shape memory polymer.

15. The delivery device ofclaim 14, wherein the shape memory polymer is biocompatible.

16. The delivery device ofclaim 12, wherein the distal holding section includes a distal tip made of a material having a lower durometer than a material forming the body portion.

17. The delivery device ofclaim 12, wherein the distal holding section includes multiple layers, with an inner layer made of a material that is harder than an outer layer.

18. The delivery device ofclaim 12, wherein the distal holding section includes a distal tip comprising a bumper configured to be atraumatic to tissue.

19. The delivery device ofclaim 12, wherein the distal holding section includes a distal tip comprising a rounded structure configured to be atraumatic to tissue.

20. The delivery device ofclaim 12, wherein one or more portions of the distal holding section comprises a flexible material.

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